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U.S. Department of Health and Human Services

Class 2 Device Recall Stratum Foot Plating System

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  Class 2 Device Recall Stratum Foot Plating System see related information
Date Initiated by Firm November 11, 2019
Create Date January 03, 2020
Recall Status1 Open3, Classified
Recall Number Z-0778-2020
Recall Event ID 84405
510(K)Number K182201  
Product Classification Screw, fixation, bone - Product Code HWC
Product Stratum MDS Screw 3.5x50mm ST
Part Number: STRM-MDS-3550ST
Code Information Lot Number: M1268  UDI: 00817701023173
Recalling Firm/
Manufacturer
Nextremity Solutions
6210 N Buffalo St
Warsaw IN 46580
For Additional Information Contact
732-683-9305
Manufacturer Reason
for Recall
Components 2mm shorter than indicated on the package label
FDA Determined
Cause 2
Packaging process control
Action Nextremity Solutions issued Urgent Medical Device Recall letter on 11/11/19 stating reason for recall, health risk and action to take: do not use, quarantine and return to Zimmer Biomet representative who will remove product, Contact customer service at 574-371-3071 between 8am -5pm(EST) M-F.
Quantity in Commerce 86 units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = Nextremity Solutions, Inc.
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